Zdrowie i gospodarka · 28/07/1995

Medical Devices; Exemption From Premarket Notification for Certain Classified Devices

The Food and Drug Administration (FDA) is exempting nine generic types of class I devices from the requirement of premarket notification. For the exempted devices, FDA has determined that manufacturers' submissions of premarket notifications are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. The exemptions allow the agency to make better use of its resources and thus better serve the public. Elsewhere in this issue of the Federal Register, FDA is publishing a withdrawal of a proposed rule to grant exemptions from premarket notification for seven other generic types of class I devices. Also, the agency is proposing to exempt an additional 12 generic types of class I devices from the requirement of premarket notification. These actions are being taken under the Medical Device Amendments of 1976.